CA2428274A1 - Device for synthesis of radiopharmaceutical products - Google Patents

Device for synthesis of radiopharmaceutical products Download PDF

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Publication number
CA2428274A1
CA2428274A1 CA002428274A CA2428274A CA2428274A1 CA 2428274 A1 CA2428274 A1 CA 2428274A1 CA 002428274 A CA002428274 A CA 002428274A CA 2428274 A CA2428274 A CA 2428274A CA 2428274 A1 CA2428274 A1 CA 2428274A1
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Canada
Prior art keywords
module
transfer
bottles
support plate
disposable
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Granted
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CA002428274A
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French (fr)
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CA2428274C (en
Inventor
Frederic Schmitz
Pierre-Emmanuel Boeyen
Vincent Tadino
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Ion Beam Applications SA
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Individual
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Expired - Lifetime legal-status Critical Current

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    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F5/00—Transportable or portable shielded containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1282—Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/0491—Sugars, nucleosides, nucleotides, oligonucleotides, nucleic acids, e.g. DNA, RNA, nucleic acid aptamers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Telephone Function (AREA)
  • Developing Agents For Electrophotography (AREA)

Abstract

The invention concerns a device for synthesis of radiopharmaceutical products based on chemical reagents contained in bottles (3a, 3b, 3c, 3d, 3e), said device comprising several reaction compartments (R´1?, R´2?), transfer means (4a, 4b, 4c, 4d, 4e, ) between said bottles (3a, 3b, 3c, 3d, 3e) and said reaction compartments (R´1?, R´2?) as well as mechanical means (8a, 8b, 8c, 8d, 8e,) acting on said transfer means(4a, 4b, 4c, 4d, 4e, ) and enabling to monitor and control mechanically the transfer of the chemical reagents. The invention is characterised in that it comprises: a fixed module (1) including at least the mechanical means (8a, 8b, 8c, 8d, 8e, ); a removable and disposable module (2), essentially in the shape of a support, whereon are arranged the transfer means (4a, 4b, 4c, 4d, 4e, ) between said bottles(3a, 3b, 3c, 3d, 3e) and said reaction compartments (R´1?, R´2?), said removable and disposable module not including any mechanical means; and means for securing (10, 11, 12a-12d, 13a-13d) said removable and disposable module (2) to said fixed module (1).

Claims (20)

1. Dispositif pour la synthèse de produits radiopharmaceutiques au départ de réactifs chimiques contenus dans des flacons (3a,3b,3c,3d,3e), ledit dispositif comprenant plusieurs compartiments de réaction (R1, R2), des moyens de transfert (4a, 4b, 4c, 4d, 4e, ...) entre lesdits flacons (3a,3b,3c,3d,3e) et lesdits compartiments de réaction (R1,R2) ainsi que des moyens mécaniques (8a,8b,8c,8d,8e,...) agissant sur lesdits moyens de transfert (4a,4b,4c,4d,4e,...) et permettant de commander et de contrôler mécaniquement le transfert des réactifs chimiques, caractérisé en ce qu'il comporte.

- un module (1) fixe comprenant au moins les moyens mécaniques (8a, 8b, 8c, 8d, 8e,...), - un module (2) détachable et jetable, se présentant essentiellement sous la forme d'une plaque support (5), sur lequel sont disposés les moyens de transfert (4a, 4b, 4c, 4d, 4e,...) entre lesdits flacons (3a,3b,3c,3d,3e) et lesdits compartiments de réaction (R1, R2), ledit module (2) jetable et détachable ne comportant aucun moyen mécanique, et - des moyens de solidarisation (10, 11, 12a-12d, 13a-13d) dudit module (2) détachable et jetable audit module (1) fixe. 1. Device for the synthesis of products radiopharmaceuticals from chemical reagents contained in vials (3a, 3b, 3c, 3d, 3e), said device comprising several reaction compartments (R1, R2), transfer means (4a, 4b, 4c, 4d, 4th, ...) between said bottles (3a, 3b, 3c, 3d, 3e) and said compartments reaction (R1, R2) as well as mechanical means (8a, 8b, 8c, 8d, 8e, ...) acting on said transfer means (4a, 4b, 4c, 4d, 4th, ...) and allowing to order and mechanically control the transfer of reagents chemical, characterized in that it comprises.

- a fixed module (1) comprising at least the means mechanical (8a, 8b, 8c, 8d, 8e, ...), - a detachable and disposable module (2), essentially in the form of a support plate (5), on which the transfer means are arranged (4a, 4b, 4c, 4d, 4e, ...) between said bottles (3a, 3b, 3c, 3d, 3e) and said reaction compartments (R1, R2), said disposable and detachable module (2) does not involving no mechanical means, and - securing means (10, 11, 12a-12d, 13a-13d) of said detachable and disposable module (2) to said module (1) fixed. 2. Dispositif selon la revendication 1, caractérisé en ce que ledit module (2) jetable comprend en outre lesdits flacons (3a,3b,3c,3d,3e) et lesdits compartiments de réaction (R1,R2). 2. Device according to claim 1, characterized in that said disposable module (2) comprises in addition to said bottles (3a, 3b, 3c, 3d, 3e) and said reaction compartments (R1, R2). 3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que les flacons (3a,3b,3c,3d,3e) sont des flacons prédosés. 3. Device according to claim 1 or 2, characterized in that the bottles (3a, 3b, 3c, 3d, 3e) are pre-dispensed bottles. 4. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce que la plaque support (5) comprend des moyens de positionnement précis des moyens de transfert (4a,4b,4c,4d,4e,...) . 4. Device according to any one of previous claims, characterized in that the plate support (5) includes precise positioning means transfer means (4a, 4b, 4c, 4d, 4th, ...). 5. Dispositif selon la revendication 4, caractérisé en ce que les moyens de positionnement sont constitués par des rainures (6) dans lesquelles viennent se placer les moyens de transfert (4a,4b,4c,4d,4e,...) . 5. Device according to claim 4, characterized in that the positioning means are formed by grooves (6) in which come place the transfer means (4a, 4b, 4c, 4d, 4th, ...). 6. Dispositif selon l'une des revendications 1 à 5, caractérisé en ce que les moyens de transfert sont des tubes (4a,4b,4c,4d,4e,...) flexibles, les moyens mécaniques (8a,8b,8c,8d,8e,...) sont des pistons, les moyens de transfert, les moyens mécaniques et les moyens de positionnement (6) étant aptes à coopérer afin de constituer des vannes . 6. Device according to one of claims 1 to 5, characterized in that the transfer means are flexible tubes (4a, 4b, 4c, 4d, 4th, ...), the means mechanical (8a, 8b, 8c, 8d, 8e, ...) are pistons, the means transfer, mechanical means and means of positioning (6) being able to cooperate in order to constitute valves. 7. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce que les moyens de solidarisation comprennent au moins une ouverture (10), des épaulements (13a-13d) et des attaches (11, 12a-12d). 7. Device according to any one of Claims 1 to 6, characterized in that the means for joining include at least one opening (10), shoulders (13a-13d) and fasteners (11, 12a-12d). 8. Dispositif selon la revendication 7, caractérisé en ce que lesdits épaulements (13a-13d) sont situés sur la plaque support (5), de préférence aux quatre coins de la plaque support (5), et sont capables de s'emboîter dans des attaches (12a-12d) situées sur le module fixe (1). 8. Device according to claim 7, characterized in that said shoulders (13a-13d) are located on the support plate (5), preferably the four corners of the support plate (5), and are capable of fit into fasteners (12a-12d) located on the fixed module (1). 9. Dispositif selon la revendication 8, caractérisé en ce que ladite ouverture (10) est également située sur la plaque support(5), de préférence au centre de ladite plaque (5), et est capable de s'emboîter dans une attache (11) située sur le module fixe (1). 9. Device according to claim 8, characterized in that said opening (10) is also located on the support plate (5), preferably in the center of said plate (5), and is capable of fitting into a clip (11) located on the fixed module (1). 10. Dispositif selon l'une des revendications précédentes, caractérisé en ce que la nature de la plaque support (5) et celle des moyens de transfert (4a,4b,4c,4d,4e) sont telles qu'elles permettent un lavage dudit module (2) jetable par autoclavage à la vapeur et/ou sa stérilisation. 10. Device according to one of claims previous, characterized in that the nature of the plate support (5) and that of the transfer means (4a, 4b, 4c, 4d, 4e) are such that they allow washing of said module (2) disposable by autoclaving with steam and / or its sterilization. 11. Dispositif selon la revendication 10, caractérisé en ce que la plaque support (5) est en ABS. 11. Device according to claim 10, characterized in that the support plate (5) is made of ABS. 12. Dispositif selon la revendication 10 ou 11, caractérisé en ce que les moyens de transfert (4a,4b,4c,4d,4e, ...) sont en silicone. 12. Device according to claim 10 or 11, characterized in that the transfer means (4a, 4b, 4c, 4d, 4th, ...) are made of silicone. 13. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il comporte des moyens d'actionnement des moyens mécaniques du module fixe (1). 13. Device according to any one of previous claims, characterized in that includes means for actuating the mechanical means of the fixed module (1). 14. Dispositif selon l'une quelconque des revendications précédentes, caractérisé en ce que les moyens d'actionnement sont constitués par un automate coopérant avec un ordinateur et faisant partie du module fixe (1). 14. Device according to any one of previous claims, characterized in that the actuation means are constituted by an automaton cooperating with a computer and being part of the module fixed (1). 15. Module (2) jetable et détachable destiné
à être associé à un module fixe (1) par des moyens de solidarisation (10, 11, 12a-12d, 13a-13d) et se présentant essentiellement sous la forme d'une plaque support (5) comprenant des moyens de positionnement des moyens de transfert (4a,4b,4c,4d,4e, ...) de réactifs chimiques. 15. Disposable and detachable module (2) intended to be associated with a fixed module (1) by means of joining (10, 11, 12a-12d, 13a-13d) and presenting essentially in the form of a support plate (5) comprising means for positioning the means of transfer (4a, 4b, 4c, 4d, 4th, ...) of chemical reagents. 16. Module (2) selon la revendication 15, caractérisé en ce qu'il comprend en outre des flacons (3a,3b,3c,3d,3e) et des compartiments de réaction (R1, R2). 16. Module (2) according to claim 15, characterized in that it further comprises bottles (3a, 3b, 3c, 3d, 3e) and reaction compartments (R1, R2). 17. Plaque selon la revendication 15 ou 16, caractérisée en ce que les moyens de positionnement sont constitués par des rainures (6) capables de loger des moyens de transfert (4a,4b,4c,4d,4e). 17. Plate according to claim 15 or 16, characterized in that the positioning means are formed by grooves (6) capable of accommodating transfer means (4a, 4b, 4c, 4d, 4e). 18. Procédé pour la synthèse de produits radiopharmaceutiques utilisant le dispositif selon l'une quelconque des revendications 1 à l4, caractérisé en ce qu'il comprend les étapes suivantes :

- on dispose les moyens de transfert (4a, 4b, 4c, 4d, 4e) sur la plaque (5) de support, - on fixe les flacons (3a-3e) contenant les réactifs chimiques à l'une des extrémités des tubes de transfert (4a,4b,4c,4d,4e), - on attache ladite plaque (5) de support avec les moyens de transfert au module fixe (1) à l'aide de moyens de solidarisation (10, 11, 12a-12d, 13a-13d), - on connecte les moyens de transfert (4a,4b,4c,4d,4e) aux différents éléments du module fixe (1), - on commande via l'automate les différentes opérations nécessaires à la synthèse des produits pharmaceutiques, y compris l'actionnement des moyens mécaniques (8a-8e). 18. Process for the synthesis of products radiopharmaceuticals using the device according to one any of claims 1 to 14, characterized in that it includes the following stages:

- we have the transfer means (4a, 4b, 4c, 4d, 4th) on the support plate (5), - the bottles (3a-3e) containing the reagents are fixed chemicals at one end of the transfer tubes (4a, 4b, 4c, 4d, 4e), - said support plate (5) is attached with the means transfer to the fixed module (1) using means of solidarity (10, 11, 12a-12d, 13a-13d), - the transfer means (4a, 4b, 4c, 4d, 4e) are connected to the different elements of the fixed module (1), - the different operations are controlled via the PLC
necessary for the synthesis of pharmaceutical products, including the actuation of mechanical means (8a-8e). 19. Procédé selon la revendication 18, caractérisé en ce qu'avant de commander les différentes opérations nécessaires à la synthèse des produits pharmaceutiques, on effectue via l'automate un test pour vérifier l'étanchéité du dispositif. 19. The method of claim 18, characterized in that before ordering the different operations required for product synthesis pharmaceuticals, a test is carried out via the automaton check the device for leaks. 20. Utilisation du dispositif selon l'une quelconque des revendications 1 à 14 ou du module jetable selon l'une des revendications 15 à 17 pour 1a synthèse de composés radiopharmaceutiques contenant des radioéléments de courte demi-vie, de préférence le 11C, le 13N, le 15O ou le 18F. 20. Use of the device according to one any of claims 1 to 14 or the disposable module according to one of claims 15 to 17 for the synthesis of radiopharmaceutical compounds containing radioactive elements short half-life, preferably 11C, 13N, 15O or the 18F.
CA2428274A 2000-12-22 2001-12-12 Device for synthesis of radiopharmaceutical products Expired - Lifetime CA2428274C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP00870323.3 2000-12-22
EP00870323A EP1216715A1 (en) 2000-12-22 2000-12-22 Synthesing device von radiopharmaceuticals
PCT/BE2001/000212 WO2002051447A1 (en) 2000-12-22 2001-12-12 Device for synthesis of radiopharmaceutical products

Publications (2)

Publication Number Publication Date
CA2428274A1 true CA2428274A1 (en) 2002-07-04
CA2428274C CA2428274C (en) 2012-09-18

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CA2428274A Expired - Lifetime CA2428274C (en) 2000-12-22 2001-12-12 Device for synthesis of radiopharmaceutical products

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US (2) US8287819B2 (en)
EP (2) EP1216715A1 (en)
JP (1) JP4293304B2 (en)
KR (1) KR100851864B1 (en)
CN (1) CN1310680C (en)
AT (1) ATE273029T1 (en)
CA (1) CA2428274C (en)
DE (1) DE60104896T2 (en)
WO (1) WO2002051447A1 (en)

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US8287819B2 (en) 2012-10-16
EP1216715A1 (en) 2002-06-26
DE60104896T2 (en) 2005-09-29
US20130030168A1 (en) 2013-01-31
US20040028573A1 (en) 2004-02-12
KR100851864B1 (en) 2008-08-13
JP2004515330A (en) 2004-05-27
ATE273029T1 (en) 2004-08-15
KR20030076578A (en) 2003-09-26
WO2002051447A1 (en) 2002-07-04
CA2428274C (en) 2012-09-18
DE60104896D1 (en) 2004-09-16
EP1343533A1 (en) 2003-09-17
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EP1343533B1 (en) 2004-08-11
CN1310680C (en) 2007-04-18

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